Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial

Macey L Levan, Madeleine M Waldram, Sandra R DiBrito, Alvin G Thomas, Fawaz Al Ammary, Shane Ottman, Jaclyn Bannon, Daniel C Brennan, Allan B Massie, Joseph Scalea, Rolf N Barth, Dorry L Segev, Jacqueline M Garonzik-Wang, Macey L Levan, Madeleine M Waldram, Sandra R DiBrito, Alvin G Thomas, Fawaz Al Ammary, Shane Ottman, Jaclyn Bannon, Daniel C Brennan, Allan B Massie, Joseph Scalea, Rolf N Barth, Dorry L Segev, Jacqueline M Garonzik-Wang

Abstract

Background: Live kidney donors (LKDs) account for nearly a third of kidney transplants in the United States. While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease. Routine screening presents an opportunity for the early detection and management of chronic conditions. Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Strategies to increase patient engagement in follow-up efforts while minimizing administrative burden are needed. We seek to evaluate the effectiveness of using small financial incentives to promote patient compliance with LKD follow-up.

Methods/design: We are conducting a two-arm randomized controlled trial (RCT) of patients who undergo live donor nephrectomy at The Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) and the University of Maryland Medical Center Transplant Center (MDUM). Eligible donors will be recruited in-person at their first post-surgical clinic visit or over the phone. We will use block randomization to assign LKDs to the intervention ($25 gift card at each follow-up visit) or control arm (current standard of care). Follow-up compliance will be tracked over time. The primary outcome will be complete (all components addressed) and timely (60 days before or after expected visit date), submission of LKD follow-up data at required 6-month, 1-year, and 2-year time points. The secondary outcome will be transplant hospital-level compliance with federal reporting requirements at each visit. Rates will be compared between the two arms following the intention-to-treat principle.

Discussion: Small financial incentivization might increase patient compliance in the context of LKD follow-up, without placing undue administrative burden on transplant providers. The findings of this RCT will inform potential center- and national-level initiatives to provide all LKDs with small financial incentives to promote engagement with post-donation monitoring efforts.

Trial registration: ClinicalTrials.gov number: NCT03090646 Date of registration: March 2, 2017 Sponsors: Johns Hopkins University, University of Maryland Medical Center Funding: The Living Legacy Foundation of Maryland.

Keywords: Care management; Financial incentive; Follow-up; Kidney transplantation; Motivation; Organ donors; Patient care management; Protocol; Quality improvement, health care; Randomized control trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic of Study Design
Fig. 2
Fig. 2
Power calculation of evaluating the effectiveness of the financial incentive intervention with 320 donors enrolled at MDJH and MDUM over 4 years

References

    1. Terasaki PI, Cecka JM, Gjertson DW, Takemoto S. High survival rates of kidney transplants from spousal and living unrelated donors. N Engl J Med. 1995;333(6):333–336. doi: 10.1056/NEJM199508103330601.
    1. Mange KC, Joffe MM, Feldman HI. Effect of the use or nonuse of long-term dialysis on the subsequent survival of renal transplants from living donors. N Engl J Med. 2001;344(10):726–731. doi: 10.1056/NEJM200103083441004.
    1. Davis CL, Delmonico FL. Living-donor kidney transplantation: a review of the current practices for the live donor. J Am Soc Nephrol. 2005;16(7):2098–2110. doi: 10.1681/ASN.2004100824.
    1. Meier-Kriesche HU, Kaplan B. Waiting time on dialysis as the strongest modifiable risk factor for renal transplant outcomes: a paired donor kidney analysis. Transplantation. 2002;74(10):1377–1381. doi: 10.1097/00007890-200211270-00005.
    1. Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, Wainright JL, Haynes CR, Snyder JJ, Kasiske BL, et al. OPTN/SRTR 2016 annual data report: kidney. Am J Transplant. 2018;18(Suppl 1):18–113. doi: 10.1111/ajt.14557.
    1. Segev DL, Muzaale AD, Caffo BS, Mehta SH, Singer AL, Taranto SE, McBride MA, Montgomery RA. Perioperative mortality and long-term survival following live kidney donation. Jama. 2010;303(10):959–966. doi: 10.1001/jama.2010.237.
    1. Lafranca JA, Hagen SM, Dols LF, Arends LR, Weimar W, Ijzermans JN, Dor FJ. Systematic review and meta-analysis of the relation between body mass index and short-term donor outcome of laparoscopic donor nephrectomy. Kidney Int. 2013;83(5):931–939. doi: 10.1038/ki.2012.485.
    1. Reeves-Daniel A, Freedman BI, Assimos D, Hartmann EL, Bleyer A, Adams PL, Westcott C, Stratta RJ, Rogers J, Farney AC, et al. Short-term renal outcomes in African American and Caucasian donors following live kidney donation. Clin Transpl. 2010;24(5):717–722. doi: 10.1111/j.1399-0012.2009.01170.x.
    1. Lentine KL, Schnitzler MA, Garg AX, Xiao H, Axelrod D, Tuttle-Newhall JE, Brennan DC, Segev DL. Race, relationship and renal diagnoses after living kidney donation. Transplantation. 2015;99(8):1723–1729. doi: 10.1097/TP.0000000000000733.
    1. Lam NN, McArthur E, Kim SJ, Prasad GV, Lentine KL, Reese PP, Kasiske BL, Lok CE, Feldman LS, Garg AX. Gout after living kidney donation: a matched cohort study. Am J Kidney Dis. 2015;65(6):925–932. doi: 10.1053/j.ajkd.2015.01.017.
    1. Garg AX, Nevis IF, McArthur E, Sontrop JM, Koval JJ, Lam NN, Hildebrand AM, Reese PP, Storsley L, Gill JS, et al. Gestational hypertension and preeclampsia in living kidney donors. N Engl J Med. 2015;372(2):124–133. doi: 10.1056/NEJMoa1408932.
    1. Lentine KL, Schnitzler MA, Xiao H, Saab G, Salvalaggio PR, Axelrod D, Davis CL, Abbott KC, Brennan DC. Racial variation in medical outcomes among living kidney donors. N Engl J Med. 2010;363(8):724–732. doi: 10.1056/NEJMoa1000950.
    1. Grams ME, Sang Y, Levey AS, Matsushita K, Ballew S, Chang AR, Chow EK, Kasiske BL, Kovesdy CP, Nadkarni GN, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374(5):411–421. doi: 10.1056/NEJMoa1510491.
    1. Muzaale AD, Massie AB, Wang MC, Montgomery RA, McBride MA, Wainright JL, Segev DL. Risk of end-stage renal disease following live kidney donation. Jama. 2014;311(6):579–586. doi: 10.1001/jama.2013.285141.
    1. Boudville N, Prasad GV, Knoll G, Muirhead N, Thiessen-Philbrook H, Yang RC, Rosas-Arellano MP, Housawi A, Garg AX. Meta-analysis: risk for hypertension in living kidney donors. Ann Intern Med. 2006;145(3):185–196. doi: 10.7326/0003-4819-145-3-200608010-00006.
    1. Locke JE, Reed RD, Massie A, MacLennan PA, Sawinski D, Kumar V, Mehta S, Mannon RB, Gaston R, Lewis CE, et al. Obesity increases the risk of end-stage renal disease among living kidney donors. Kidney Int. 2017;91(3):699–703. doi: 10.1016/j.kint.2016.10.014.
    1. Anjum S, Muzaale AD, Massie AB, Bae S, Luo X, Grams ME, Lentine KL, Garg AX, Segev DL. Patterns of end-stage renal disease caused by diabetes, hypertension, and glomerulonephritis in live kidney donors. Am J Transplant. 2016;16(12):3540–3547. doi: 10.1111/ajt.13917.
    1. Massie A, Fahmy L, Henderson M, Thomas A, Snyder J, Segev D. Pre-donation eGFR, early post-donation eGFR, and subsequent ESRD risk in living kidney donors. Am J Transplant. 2017;17(suppl 3).
    1. Schold JD, Buccini LD, Rodrigue JR, Mandelbrot D, Goldfarb DA, Flechner SM, Kayler LK, Poggio ED. Critical factors associated with missing follow-up data for living kidney donors in the United States. Am J Transplant. 2015;15(9):2394–2403. doi: 10.1111/ajt.13282.
    1. Henderson ML, Thomas AG, Shaffer A, Massie AB, Luo X, Holscher CM, Purnell TS, Lentine KL, Segev DL. The national landscape of living kidney donor follow-up in the United States. Am J Transplant. 2017;17(12):3131–3140. doi: 10.1111/ajt.14356.
    1. Waterman AD, Dew MA, Davis CL, McCabe M, Wainright JL, Forland CL, Bolton L, Cooper M. Living-donor follow-up attitudes and practices in U.S. kidney and liver donor programs. Transplantation. 2013;95(6):883–888. doi: 10.1097/TP.0b013e31828279fd.
    1. Mandelbrot DA, Pavlakis M. Living donor practices in the United States. Adv Chronic Kidney Dis. 2012;19(4):212–219. doi: 10.1053/j.ackd.2012.04.010.
    1. Sutherland K, Christianson JB, Leatherman S. Impact of targeted financial incentives on personal health behavior: a review of the literature. Med Care Res Rev. 2008;65(6 Suppl):36s–78s. doi: 10.1177/1077558708324235.
    1. Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015;372(22):2108–2117. doi: 10.1056/NEJMoa1414293.
    1. Mehta SJ, Feingold J, Vandertuyn M, Niewood T, Cox C, Doubeni CA, Volpp KG, Asch DA. Active choice and financial incentives to increase rates of screening colonoscopy– a randomized controlled trial. Gastroenterology. 2017;153(5):1227–1229.e1222. doi: 10.1053/j.gastro.2017.07.015.
    1. Kimmel SE, Troxel AB, Loewenstein G, Brensinger CM, Jaskowiak J, Doshi JA, Laskin M, Volpp K. Randomized trial of lottery-based incentives to improve warfarin adherence. Am Heart J. 2012;164(2):268–274. doi: 10.1016/j.ahj.2012.05.005.
    1. Malotte KC, Ledsky R, Hogben M, Larro M, Middlestadt S, St. Lawrence JS, Olthoff G, Settlage RH, Van Devanter NL, Group TGS Comparison of methods to increase repeat testing in persons treated for gonorrhea and/or chlamydia at public sexually transmitted disease clinics. Am Sex Transm Dis Assoc. 2004;31(11):637–642. doi: 10.1097/01.olq.0000143083.38684.9d.
    1. Giles EL, Robalino S, McColl E, Sniehotta FF, Adams J. The effectiveness of financial incentives for health behaviour change: systematic review and meta-analysis. PLoS One. 2014;9(3):e90347. doi: 10.1371/journal.pone.0090347.
    1. Cahill K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2008;(3):Cd004307.
    1. Paul-Ebhohimhen V, Avenell A. Systematic review of the use of financial incentives in treatments for obesity and overweight. Obes Rev. 2008;9(4):355–367. doi: 10.1111/j.1467-789X.2007.00409.x.
    1. Wall J, Mhurchu CN, Blakely T, Rodgers A, Wilton J. Effectiveness of monetary incentives in modifying dietary behavior:a review of randomized, controlled trials. Nutr Rev. 2006;64(12):518–531. doi: 10.1111/j.1753-4887.2006.tb00185.x.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Health TNIo. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information in NIH Guide Notice. In., vol. NOT-OD-16-149. 2016.
    1. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. In.: International Committee of Medical Journal Editors. 2017.
    1. Davis CL, Cooper M. The state of U.S. living kidney donors. Clin J Am Soc Nephrol. 2010;5(10):1873–1880. doi: 10.2215/CJN.01510210.

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